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Aneurysm, IntracranialCOVERNCT02820779

New Covered Stent (Willis) for the Endovascular Reconstruction of Intracranial Vessel Wall Defects Registry

A study testing WILLIS in people with Aneurysm, Intracranial and Carotid-Cavernous Sinus Fistula, run by Xuanwu Hospital, Beijing at 11 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to evaluate the effectiveness, long-term safety and explore the safety and efficacy factors WILLIS™ intracranial stent graft system in clinical applications. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
WILLIS
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
11 sitesChina
Study dates
Jun 2016to May 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age over 18;
  • Arterial wall defects conformed by imaging examination due to internal carotid artery, vertebral artery aneurysms or various causes;
  • Target lesion vessel reference diameter 3.5-4.5mm;
  • Investigators believe that the patient is suitable for the interventional therapy of WILLIS intracranial covered stent;
  • Participate in the study voluntarily, accept follow up study and signed Informed Consent Form.

Who cannot join

  • Existence of branch artery (eg anterior choroidal artery, posterior communicating artery, posterior inferior cerebellar artery, etc.) of target lesion which may cause severe neurological dysfunction after occlusion;
  • No suitable vessel entrance, or diseased artery extremely tortuous;
  • Coagulation disorders or serious heart, liver, kidney dysfunction or systemic infection, which not suitable for interventional treatment;
  • Life expectancy <1 year;
  • Contraindications to heparin, aspirin, clopidogrel, anesthesia, X-ray or contrast agents;
  • Mental disorder

Trial locations and contacts

11 sites in 1 country.

Hongqi Zhang, MD contact

hqzh@vip.163.com

11 sites in 1 country

China11 sites

  • West China Hospital Sichuan University

    Chengdu, Sichuan, 610041

  • Nanfang hospital, Southern Medical university

    Guangzhou, Guangdong, 510515

  • The 2nd Affiliated Hospital of Harbin Medical university

    Harbin, Heilongjiang, 150001

  • The First Affiliated Hospital of Harbin Medical university

    Harbin, Heilongjiang, 150001

  • Qilu Hospital Of Shang Dong University

    Jinan, Shandong, 250012

  • Shandong Provincial Hospital

    Jinan, Shandong, 250021

  • Tongji Hospital

    Shanghai, 200333

  • ShanXi Provincial People's Hospital

    Taiyuan, Shanxi, 030012

  • The First Affiliated Hospital Of Xinjiang Medical University

    Ürümqi, Xinjiang, 830054

  • Tangdu Hospital Fourth Military Medical University

    Xi’an, Shanxi, 710038

  • First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

Other trials in China

About this study

The purpose of this study is to evaluate the effectiveness, long-term safety and explore the safety and efficacy factors WILLIS™ intracranial stent graft system in clinical applications.

Read the detailed description

Intracranial aneurysm is a cerebrovascular disorder in which weakness in the wall of a cerebral artery or vein causes a localized dilation or ballooning of the blood vessel.WILLIS® intracranial stent graft system is indicated for the treatment of intracranial aneurysms.

This study is a multi-center, prospective registration study.

Recruiting 100 specific patients to undergo a treatment with the WILLIS intracranial stent graft system, while giving the anti-platelet aggregation drugs and other medical therapy.

Patients enrolled will undergo a one-year follow-up.

Being tested
WILLIS
Keywords
Willis, Intracranial aneurysms
Medical subject headings
Intracranial Aneurysm, Carotid-Cavernous Sinus Fistula

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WILLISDevice

    Also called WILLIS® intracranial stent graft system

    WILLIS® intracranial stent graft system is composed of the stent, delivery system, cobalt-based alloy stent and PTFE graft. It can effectively shunt the blood flow and keep it off of the aneurysm wall.

Study groups in NCT02820779
Study groupRoleWhat they receive
WILLISExperimentalPatients undergo WILLIS intracranial covered stent interventional treatment
Receives: Device: WILLIS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1-year treatment success rate

    Treatment success is defined as target lesion such as aneurysms, cavernous fistula shows no shadow and target vessel stenosis of no more than 50%.

    Measured: 12 months

Secondary outcomes (16)

  1. Technically success rate of surgery

    Technically success is defined as stent reach the target lesion and successfully released.

    Measured: immediately after surgery

  2. Target lesion treatment success rate

    Measured: Immediately after surgery

  3. X-ray exposure time

    Measured: 24 hours

  4. Operative time

    Measured: through surgery completion

  5. Surgery-related complications or death

    Measured: 12 months

  6. Various causes of death

    Measured: the perioperative period to 12 months

  7. Recurrence of target lesion

    Measured: 12 months

  8. Target lesion was treated by interventional or surgical therapy once again

    Measured: 12 months

  9. Postoperative ipsilateral symptomatic stroke

    Ipsilateral symptomatic stroke is defined as the target lesion is conformed occurs ipsilateral stroke and the increase of NIHSS score point ≥4.

    Measured: 30 days; 6 months; 12 months

  10. Occurs intracranial hemorrhagic stroke that caused by aneurysm rupture

    Measured: 12 months

  11. Occurs intracranial ischemic stroke that caused by thrombus

    Measured: 12 months

  12. All adverse events

    Measured: 12 months

  13. Device-related serious adverse events

    Measured: 12 months

  14. Target lesion appears stenosis 12 months after surgery

    Stenosis is defined as target stenosis ≥50%

    Measured: 12 months

  15. Modified Rankin Scale

    Measured: 30 days; 6 months; 12 months

  16. NIHSS

    Measured: 30 days; 6 months; 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionMay 2019 (estimated)
  4. Study completionMay 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02820779
Sponsor's protocol ID
COVER 001
Acronym
COVER
Status last verified
Jun 2016
First submitted
23 Jun 2016
Last updated
1 Jul 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing WILLIS in people with Aneurysm, Intracranial and Carotid-Cavernous Sinus Fistula, run by Xuanwu Hospital, Beijing at 11 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hongqi Zhang, MD (hqzh@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1-year treatment success rate (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02820779.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2016.

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